(52 days)
The Pulmo-Mist compressor is designed for use by adult or pediatric patients requiring aerosolized medications.
The Pulmo-Mist Nebulizer Compressor is intended to be used to supply a continuous positive pressure to a nebulizer device for the purpose of generating an aerosol medicine.
The Pulmo-Mist compressor is an electrically powered piston type compressor that provides approximately 6 I/min of air flow against a back pressure of 10 psig. It is designed to supply air to a small volume nebulizer. The package optionally contains a legally marketed small volume disposable nebulizer kit, specifically the Westmed "VIXONE®", manufactured by Westmed, Inc. and private labeled for distribution by Nidek Medical Products, in the original manufacturer's unopened package, Each such package includes a mouthpiece, a nebulizer, a connector tube and flexible air tubing and labeling. The nebulization particle size varies slightly depending on the nebulizer used and on the viscosity of the material being nebulized. When used with the VIXONE, the MMAD is approximately 1 µm with a saline solution. Other manufacturers of small volume nebulizers report similar values for similar flow rates.
The Pulmo-Mist compressor is a portable unit. It weighs approximately 3.2 pounds and has dimensions of 7.5 in w x 4.5 in h x 7.5 in d.
The provided text describes the 510(k) submission for the Nidek Medical Products, Inc. Pulmo-Mist Compressor (K020797). This device is a physical medical device (a compressor for nebulizers) and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance) are not applicable to this submission.
However, I can extract the acceptance criteria and the study performed related to its regulatory approval as a traditional medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Electrical Performance | Home Use Respiratory Devices (March 1992 Reviewer Guidance) | Met all required performance criteria |
| Mechanical Performance | Home Use Respiratory Devices (March 1992 Reviewer Guidance) | Met all required performance criteria |
| Environmental Performance | Home Use Respiratory Devices (March 1992 Reviewer Guidance) | Met all required performance criteria |
| Safety Standards | UL544 (Medical and Dental Equipment) | Designed according to UL standard |
| UL1431 (Personal Hygiene and Healthcare Appliances) | Designed according to UL standard | |
| Functionality | Functioned as intended (e.g., providing ~6 L/min airflow against 10 psig back pressure for nebulization) | Functioned as intended |
| Technical Equivalence | Component similarity to predicate (a.c. motor driven compressor, ABS thermoplastic enclosure, wiring, switch, interconnecting tubing) | Technically equivalent to referenced legally marketed device |
| Electromagnetic Compatibility | No microprocessors or other electronic components that emit or are susceptible to electromagnetic interference | Device contains no such components, implying inherent compatibility |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified as this is a physical device. The testing was likely conducted on a limited number of units of the Pulmo-Mist Compressor.
- Data Provenance: The device was submitted by Nidek Medical Products, Inc. in Birmingham, AL, USA. The testing was conducted in the context of US regulatory approval (FDA 510(k) process). It's a prospective evaluation of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a physical device for which performance is measured against engineering specifications and industry standards, not against expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Performance testing for this type of device does not involve adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by adherence to engineering specifications, electrical and mechanical safety standards (UL544, UL1431), and industry performance guidelines (FDA Reviewer Guidance for Home Use Respiratory Devices). Its functionality is assessed based on its ability to generate the specified airflow and pressure.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Study Description:
The study proving the device meets the acceptance criteria was a performance testing study conducted by Nidek Medical Products, Inc. (or a designated testing facility) on the Pulmo-Mist Compressor.
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Methodology: The device was assessed against specific benchmarks and standards.
- Regulatory Guidance: The testing followed the Anesthesiology and Respiratory Devices Branch's "Reviewer Guidance for Home Use Respiratory Devices" (March 1992) and "Reviewer Guidance for Premarket Notification Submissions" (November 1993).
- Safety Standards: Compliance with Underwriter's Laboratory (UL) standards UL544 (Medical and Dental Equipment) and UL 1431 (Personal Hygiene and Healthcare Appliances) was also a critical component.
- Technical Equivalence: The submission also highlighted the technical equivalence of the Pulmo-Mist compressor to the legally marketed predicate device (Invacare Model IRC 1001 Env) by identifying common components and design principles (same motor supplier, similar enclosure, wiring, etc.).
- Functionality: Performance aspects like airflow rate (approximately 6 L/min) and pressure (10 psig back pressure) were likely measured and verified. The nebulization particle size reference (approx. 1 µm MMAD with VIXONE and saline) is a characteristic of the nebulizer when used with the compressor, not directly the compressor itself, but implies the compressor provides adequate power for this effect.
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Results: The "Performance Data" section explicitly states: "The Pulmo-Mist compressor met all the required performance criteria and functioned as intended." It also notes: "Summary results for the legally marketed device show equivalent performance," reinforcing the substantial equivalence claim.
In summary, for K020797, the "study" was a series of engineering, electrical, mechanical, and safety tests conducted in accordance with recognized standards and FDA guidance documents to demonstrate that the physical device functions as intended and is substantially equivalent to a predicate device.
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.